Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma

NCT07136519 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PJ2025-005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the efficacy, adverse reactions, nutritional status analysis, and quality of life analysis of Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3 in the treatment of locally advanced nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

Toripalimab; Omega-3

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival period

  It refers to the probability of disease progression or death from any cause objectively recorded from a random date within two years, evaluated according to RECIST v1.1.

  From enrollment to the end of treatment at 2 years

Secondary Outcomes (5)

• objective response rate

  From enrollment to the end of treatment at 2 years

• Overall survival

  From enrollment to the end of treatment at 2 years

• Adverse reactions

  From enrollment to the end of treatment at 2 years

• Quality of life score

  From enrollment to the end of treatment at 2 years

• Nutritional status analysis

  From enrollment to the end of treatment at 2 years

Study Arms (1)

Toripalimab Plus Omega-3

EXPERIMENTAL

Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3

Drug: Toripalimab; Dietary Supplement: Omega-3; Radiation: radiotherapy; Drug: Paclitaxel (albumin bound); Drug: Cisplatin

Interventions

Toripalimab DRUG

240mg Q3W

Also known as: not have

Toripalimab Plus Omega-3

Omega-3 DIETARY_SUPPLEMENT

During radiotherapy, take 6 capsules once a day

Also known as: not have

Toripalimab Plus Omega-3

radiotherapy RADIATION

radiotherapy

Also known as: not have

Toripalimab Plus Omega-3

Paclitaxel (albumin bound) DRUG

260mg/m2 d1,Q3W

Also known as: not have

Toripalimab Plus Omega-3

Cisplatin DRUG

80mg/m2 d2, Q3W

Also known as: not have

Toripalimab Plus Omega-3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent can be provided, and understanding and compliance with research requirements and evaluation schedules are required.
• On the date of signing the informed consent form, the age range is between 18 and 65 years old (or the legal age specified by local laws).
• Pathological diagnosis is non keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, i.e. WHO classification II or III).
• Clinical staging is anyTN2-3M0 or T4N1M0 (AJCC8th/UICC staging).
• ECOG score is 0-1 points.
• Hemoglobin (HGB) ≥ 90g/L, white blood cell (WBC) ≥ 4.0 × 109/L, platelet (PLT) ≥ 100 × 109/L.
• Liver function: ALT and AST\<2.5 times the upper limit of normal (ULN), total bilirubin\<2.0 × UL, serum albumin ≥ 28g/L.
• Renal function: Serum creatinine\<1.5 × ULN or creatinine clearance rate (CrCl) calculated value ≥ 60mL/min (Cockcroft Gault formula).
• Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).
• The international normalized ratio (INR) and activated partial thromboplastin time (APTT) are ≤ 1.5 × ULN (unless the subject is receiving anticoagulant treatment and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant treatment at the time of screening).

You may not qualify if:

• Nasopharyngeal cancer patients with recurrence and distant metastasis.
• Pathology shows keratinized squamous cell carcinoma (WHO classification type I).
• Patients who have undergone radiotherapy or systemic chemotherapy before.
• Pregnant or lactating women who are in the reproductive period and have not taken effective contraceptive measures.
• HIV positive.
• Have suffered from other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ).
• Patients who have been treated with immune checkpoint inhibitors (CTLA-4, PD-1, PD-L1, etc.).
• Patients with immunodeficiency diseases and a history of organ transplantation.
• Patients who have been treated with high-dose corticosteroids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
• Patients with significantly impaired heart, liver, lung, kidney, and bone marrow function.
• Simultaneously using other investigational drugs or in other clinical trials.
• Refusal or inability to sign the informed consent form for participation in the trial.
• Individuals with personality or mental disorders, without civil capacity or with limited civil capacity.
• hepatitis B B surface antigen (HBsAg) is positive and the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) is ≥ 1000 cps/ml.
• Patients with positive HCV antibody test results are only eligible for this study if their HCV RNA polymerase chain reaction test results are negative.

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab; Docosahexaenoic Acids; Radiotherapy; Taxes; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Therapeutics; Economics; Health Care Economics and Organizations; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Haiqing Luo, doctor

  Guangdong Medical University Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiqing Luo, doctor

CONTACT

8613729196345; hqluo@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Head and Neck Oncology Department

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 22, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will become available 6 months after the primary study results are published in a peer - reviewed journal. The data will remain accessible for a period of 5 years to facilitate secondary analyses and research replication.
• Access Criteria: To access IPD, researchers must: (1) Be affiliated with a recognized academic or research institution; (2) Submit a request detailing the research question, methodology, and how the data will contribute to advancing knowledge in the field; (3) Provide evidence of ethical approval from their local IRB for the proposed secondary analysis; (4) Agree to use de - identified data only and not attempt to re - identify participants. Access is granted at the discretion of the study's data governance board after a full review of the request.